{"id":7169,"date":"2023-07-21T00:42:05","date_gmt":"2023-07-21T00:42:05","guid":{"rendered":"\/\/smallcapscn.x5view.co\/?p=7169"},"modified":"2023-08-29T18:01:18","modified_gmt":"2023-08-29T18:01:18","slug":"incannex-submits-key-application-fda-new-treatment-sleep-apnoea-market","status":"publish","type":"post","link":"https:\/\/smallcapscn.x5view.co\/?p=7169","title":{"rendered":"Incannex \u5411\u7f8e\u56fdFDA\u63d0\u4ea4\u91cd\u8981\u7533\u8bf7\uff0c\u4ee5\u5f00\u62d3\u4ef7\u503c 150 \u4ebf\u7f8e\u5143\u7684\u7761\u7720\u547c\u5438\u6682\u505c\u5e02\u573a"},"content":{"rendered":"

\u5904\u4e8e\u4e34\u5e8a\u9636\u6bb5\u7684\u5236\u836f\u516c\u53f8 Incannex Healthcare\uff08ASX\uff1aIHL\uff09\u9488\u5bf9 150 \u4ebf\u7f8e\u5143\u7684\u7761\u7720\u547c\u5438\u6682\u505c\u5e02\u573a\u5f00\u53d1\u7684\u65b0\u4ea7\u54c1\u83b7\u5f97\u6279\u51c6\uff0c\u8fd9\u662f\u8be5\u516c\u53f8\u53d6\u5f97\u7684\u53c8\u4e00\u4e2a\u91cc\u7a0b\u7891\u3002<\/p>\n

\u8be5\u516c\u53f8\u5df2\u5411\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u6210\u529f\u63d0\u4ea4\u4e86\u5176\u72ec\u7279\u7684 IHL-42X \u65b0\u836f\u7814\u53d1\uff08IND\uff09\u7533\u8bf7\uff0c\u76f8\u4fe1\u8be5\u4ea7\u54c1\u80fd\u7f13\u89e3\u4e0e\u963b\u585e\u6027\u7761\u7720\u547c\u5438\u6682\u505c\u6cbb\u7597\u76f8\u5173\u7684\u8bb8\u591a\u95ee\u9898\u3002<\/p>\n

\u76ee\u524d\uff0c\u6cbb\u7597\u7761\u7720\u547c\u5438\u6682\u505c\u7684\u4e3b\u8981\u65b9\u6cd5\u662f\u6301\u7eed\u6c14\u9053\u6b63\u538b\u7597\u6cd5\uff08CPAP\uff09\u3002\u5bf9\u8bb8\u591a\u4eba\u6765\u8bf4\uff0c\u665a\u4e0a\u4f7f\u7528 CPAP \u673a\u5668\u592a\u4e0d\u8212\u670d\u4e86\u3002<\/p>\n

CPAP \u662f\u5c06\u9762\u7f69\u7ed1\u5728\u4eba\u7684\u8138\u4e0a\uff0c\u9762\u7f69\u4e0e\u8f6f\u7ba1\u548c\u6c14\u6cf5\u76f8\u8fde\uff0c\u5f53\u4eba\u8bd5\u56fe\u5165\u7761\u65f6\uff0c\u6c14\u6cf5\u4f1a\u5c06\u52a0\u538b\u7684\u7a7a\u6c14\u9001\u5165\u4eba\u7684\u53e3\u9f3b\u4e2d\u3002<\/p>\n

\u66f4\u7b80\u5355\u7684\u6cbb\u7597<\/h2>\n

Incannex \u516c\u53f8\u7684 IHL-42X \u7597\u6cd5\u91c7\u7528\u5c48\u5927\u9ebb\u915a\uff08\u4e00\u79cd\u5408\u6210\u7684\u56db\u6c22\u5927\u9ebb\u915a\uff08THC\uff09\uff09\u548c\u4e59\u9170\u5511\u80fa\uff08\u4e00\u79cd\u78b3\u9178\u9150\u9176\u6291\u5236\u5242\uff09\u7684\u7ec4\u5408\u5242\u91cf\u3002<\/p>\n

\u65e9\u4e9b\u65f6\u5019\u7684\u4e00\u9879\u4e8c\u671f\u6982\u5ff5\u9a8c\u8bc1\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u57fa\u7ebf\u8bc4\u4f30\u7ed3\u679c\u76f8\u6bd4\uff0cIHL-42X \u53ef\u4f7f\u547c\u5438\u6682\u505c-\u4f4e\u901a\u6c14\u6307\u6570\uff08AHI\uff09\u5e73\u5747\u964d\u4f4e 50.7%\uff0c25% \u7684\u53c2\u4e0e\u8005\u7684 AHI \u964d\u4f4e\u5e45\u5ea6\u8d85\u8fc7 80%\u3002<\/p>\n

\u91cd\u8981\u7684\u662f\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u672a\u62a5\u544a\u4e25\u91cd\u7684\u6cbb\u7597\u4e0d\u826f\u4e8b\u4ef6\uff0c\u800c\u4e14\u5728\u591c\u95f4\u7528\u836f\u540e\u7684\u7b2c\u4e8c\u5929\u65e9\u4e0a\uff0c\u8840\u6db2\u4e2d\u7684\u56db\u6c22\u5927\u9ebb\u915a\u6c34\u5e73\u4f4e\u4e8e\u9a7e\u9a76\u80fd\u529b\u53d7\u635f\u7684\u9650\u5ea6\u3002<\/p>\n

\u4e0b\u4e00\u7ec4\u8bd5\u9a8c<\/h2>\n

Incannex \u73b0\u5df2\u5411 FDA \u63d0\u4ea4\u4e86 IND \u6863\u6848\uff0c\u8be5\u6863\u6848\u7531 IHL-42X \u53ca\u5176\u6d3b\u6027\u836f\u7269\u6210\u5206\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7efc\u5408\u6a21\u5757\u7ec4\u6210\u3002<\/p>\n

\u5b83\u8fd8\u5305\u62ec\u6709\u5173 IHL-42X \u836f\u7269\u4ea7\u54c1\u7684\u5f00\u53d1\u3001\u751f\u4ea7\u3001\u8d28\u91cf\u548c\u7a33\u5b9a\u6027\u7684\u8be6\u7ec6\u4fe1\u606f\uff0c\u4ee5\u53ca 2\/3 \u671f IND \u5f00\u653e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e34\u5e8a\u65b9\u6848\u548c\u7814\u7a76\u4eba\u5458\u4fe1\u606f\u3002<\/p>\n

Incannex \u516c\u53f8\u8463\u4e8b\u603b\u7ecf\u7406\u517c\u9996\u5e2d\u6267\u884c\u5b98 Joel Latham \u8bf4\uff0c\u5411FDA\u63d0\u4ea4IND\u5bf9\u4e8e\u516c\u53f8\u83b7\u5f97\u76d1\u7ba1\u90e8\u95e8\u6279\u51c6\u3001\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u4ee5\u53ca\u4e0eFDA\u8fdb\u884c\u79d1\u5b66\u5bf9\u8bdd\u81f3\u5173\u91cd\u8981\uff0c\u540c\u65f6\u4e5f\u662f\u516c\u53f8\u5728\u7f8e\u56fd\u63a8\u8fdb\u7814\u7a76\u836f\u7269\u5f00\u53d1\u9636\u6bb5\u7684\u5173\u952e\u3002<\/p>\n

“FDA\u5bf9IND\u7533\u8bf7\u7684\u5ba1\u67e5\u8fc7\u7a0b\u5305\u62ec\u5bf9\u79d1\u5b66\u3001\u4e34\u5e8a\u548c\u5b89\u5168\u65b9\u9762\u7684\u8bc4\u4f30\uff0c\u4ee5\u786e\u4fdd\u62df\u8bae\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7b26\u5408\u76d1\u7ba1\u8981\u6c42\u3002”<\/p>\n

\u516c\u53f8\u63d0\u4ea4\u7684 IND \u6587\u4ef6\u5305\u62ec\u5173\u952e IND \u5f00\u653e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u7ec6\u8282\u3002<\/p>\n

\u8fd9\u5c06\u662f\u4e00\u9879\u591a\u7ad9\u70b9 2\/3 \u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5c06\u5728 52 \u5468\u7684\u6cbb\u7597\u671f\u5185\uff0c\u8bc4\u4f30 IHL-42X \u5728\u6210\u529f\u7684 2 \u671f\u6982\u5ff5\u9a8c\u8bc1\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u8868\u73b0\u6700\u597d\u7684\u4e24\u4e2a\u5242\u91cf\uff0c\u662f\u5426\u9002\u7528\u4e8e\u4e0d\u8010\u53d7\u3001\u4e0d\u7b26\u5408\u8981\u6c42\u6216\u5bf9\u6c14\u9053\u6b63\u538b\u7597\u6cd5\u4e0d\u719f\u6089\u7684\u7761\u7720\u547c\u5438\u6682\u505c\u75c7 (OSA) \u60a3\u8005\u3002<\/p>\n

\u8bd5\u9a8c\u8ba1\u5212\u5305\u62ec\u5728\u6574\u4e2a\u8bd5\u9a8c\u671f\u95f4\u7ed9\u53c2\u4e0e\u8005\u670d\u7528\u4e00\u79cd IHL-42X\u3001\u5c48\u5927\u9ebb\u915a\u3001\u4e59\u9170\u5511\u80fa\u6216\u5b89\u6170\u5242\u3002<\/p>\n

\u6240\u6709\u53c2\u4e0e\u8005\u90fd\u5c06\u6bcf\u5929\u586b\u5199\u7761\u7720\u8d28\u91cf\u8c03\u67e5\u8868\uff0c\u6bcf\u6708\u53c2\u52a0\u95e8\u8bca\uff0c\u4ee5\u8bc4\u4f30\u7761\u7720\u529f\u80fd\u7ed3\u679c\u3001\u8ba4\u77e5\u529f\u80fd\u4ee5\u53ca\u5176\u4ed6\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u63aa\u65bd\u3002<\/p>\n

\u4e0b\u4e00\u9636\u6bb5\u5c06\u6bcf\u4e09\u4e2a\u6708\u8fdb\u884c\u4e00\u6b21\u901a\u5bb5\u591a\u5bfc\u7761\u7720\u76d1\u6d4b\uff0c\u4ee5\u786e\u5b9a\u6cbb\u7597\u5bf9\u60a3\u8005\u547c\u5438\u6682\u505c\u6307\u6570\uff08AHI\uff09\u548c\u5176\u4ed6\u4e00\u7cfb\u5217\u7761\u7720\u53c2\u6570\u7684\u5f71\u54cd\u3002\u6240\u6709\u836f\u7269\u6cbb\u7597\u90fd\u5c06\u4e0e\u5b89\u6170\u5242\u8fdb\u884c\u6bd4\u8f83\u3002<\/p>\n

\u4e3b\u8981\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\u8005\u5df2\u786e\u5b9a<\/h2>\n

Incannex \u4e8e 6 \u6708\u5ba3\u5e03\uff0c\u83b7\u5f97\u795e\u7ecf\u5b66\u548c\u7761\u7720\u533b\u5b66\u8ba4\u8bc1\u7684 John Douglas Hudson \u535a\u58eb\u548c\u62e5\u6709\u4fc4\u4ea5\u4fc4\u5dde\u7acb\u5927\u5b66\u4e34\u5e8a\u548c\u7814\u7a76\u5fc3\u7406\u5b66\u535a\u58eb\u5b66\u4f4d\u7684 Russell Rosenberg \u535a\u58eb\u5c06\u62c5\u4efb\u8bd5\u9a8c\u7684\u4e3b\u8981\u7814\u7a76\u4eba\u5458\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

\u5904\u4e8e\u4e34\u5e8a\u9636\u6bb5\u7684\u5236\u836f\u516c\u53f8 Incannex Healthcare\uff08ASX\uff1aIHL\uff09\u9488\u5bf9 150 \u4ebf\u7f8e\u5143\u7684\u7761\u7720\u547c\u5438\u6682\u505c\u5e02\u573a\u5f00\u53d1\u7684\u65b0\u4ea7\u54c1\u83b7\u5f97\u6279\u51c6\uff0c\u8fd9\u662f\u8be5\u516c\u53f8\u53d6\u5f97\u7684\u53c8\u4e00\u4e2a\u91cc\u7a0b\u7891\u3002 \u8be5\u516c\u53f8\u5df2\u5411\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u6210\u529f\u63d0\u4ea4\u4e86\u5176\u72ec\u7279\u7684 IHL-42X \u65b0\u836f\u7814\u53d1\uff08IND\uff09\u7533\u8bf7\uff0c\u76f8\u4fe1\u8be5\u4ea7\u54c1\u80fd\u7f13\u89e3\u4e0e\u963b\u585e\u6027\u7761\u7720\u547c\u5438\u6682\u505c\u6cbb\u7597\u76f8\u5173\u7684\u8bb8\u591a\u95ee\u9898\u3002 \u76ee\u524d\uff0c\u6cbb\u7597\u7761\u7720\u547c\u5438\u6682\u505c\u7684\u4e3b\u8981\u65b9\u6cd5\u662f\u6301\u7eed\u6c14\u9053\u6b63\u538b\u7597\u6cd5\uff08CPAP\uff09\u3002\u5bf9\u8bb8\u591a\u4eba\u6765\u8bf4\uff0c\u665a\u4e0a\u4f7f\u7528 CPAP \u673a\u5668\u592a\u4e0d\u8212\u670d\u4e86\u3002 CPAP \u662f\u5c06\u9762\u7f69\u7ed1\u5728\u4eba\u7684\u8138\u4e0a\uff0c\u9762\u7f69\u4e0e\u8f6f\u7ba1\u548c\u6c14\u6cf5\u76f8\u8fde\uff0c\u5f53\u4eba\u8bd5\u56fe\u5165\u7761\u65f6\uff0c\u6c14\u6cf5\u4f1a\u5c06\u52a0\u538b\u7684\u7a7a\u6c14\u9001\u5165\u4eba\u7684\u53e3\u9f3b\u4e2d\u3002 \u66f4\u7b80\u5355\u7684\u6cbb\u7597 Incannex \u516c\u53f8\u7684 IHL-42X \u7597\u6cd5\u91c7\u7528\u5c48\u5927\u9ebb\u915a\uff08\u4e00\u79cd\u5408\u6210\u7684\u56db\u6c22\u5927\u9ebb\u915a\uff08THC\uff09\uff09\u548c\u4e59\u9170\u5511\u80fa\uff08\u4e00\u79cd\u78b3\u9178\u9150\u9176\u6291\u5236\u5242\uff09\u7684\u7ec4\u5408\u5242\u91cf\u3002 \u65e9\u4e9b\u65f6\u5019\u7684\u4e00\u9879\u4e8c\u671f\u6982\u5ff5\u9a8c\u8bc1\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u57fa\u7ebf\u8bc4\u4f30\u7ed3\u679c\u76f8\u6bd4\uff0cIHL-42X \u53ef\u4f7f\u547c\u5438\u6682\u505c-\u4f4e\u901a\u6c14\u6307\u6570\uff08AHI\uff09\u5e73\u5747\u964d\u4f4e 50.7%\uff0c25% 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